Molecular Diagnostics
News on lab-developed tests and emerging diagnostic technologies.
Siemens Healthineers, Thermo Fisher Scientific, Acon, Hologic, Others Gain FDA Clearances in November
The agency granted marketing clearances to tests for C-reactive protein, COVID-19, T. vaginalis, chlamydia, and use or overdose of certain drugs.
The firm is offering molecular diagnostic testing and clinical trial services to bridge knowledge gaps and increase access to personalized care locally.
Quest Diagnostics Wins Contract From CDC to Assess US Hepatitis C Burden
Quest will perform HCV antibody testing and molecular RNA testing on de-identified remnant specimens randomly selected from clinical test specimens.
A previous analysis of CMS billing data found two contractors had seen particularly high rates of billing for tier two molecular pathology procedure codes, raising concerns about fraud.
Personalis believes the move will get its minimal residual disease test into the hands of doctors more quickly while it continues to validate additional indications.